On November 8, 2023, the official website of China's National Medical Products Administration (NMPA) announced that Juventas had submitted its CAR-T product.Naciorl Injection(Former name: Heceloncell)The marketing application has been approved for the treatment of adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.（r/r B-ALL）Notably, this is also the first CAR-T product for the treatment of leukemia to be approved for marketing in China.

November 9, 2023(November 8, US time)Hutchmed Announces Fruzaqla, a Drug Co-developed with Partner Takeda(fruquintinib)Approved in the United States for entry into the local pharmaceutical market for the treatment of advanced colorectal cancer. This is the first and only approved treatment in the U.S. for previously treated metastatic colorectal cancer, targeting all three anti-vascular endothelial growth factors.（VEGF）Highly selective receptor inhibitor.

Naciorl Injection(CNCT19 Cell Injection, Inaticabtagene Autoleucel)It is an autologous CAR-T product based on a lentiviral vector, featuring a globally unique CD19 scFv (HI19a) structure and internationally leading production technology. The drug has successively obtained three Investigational New Drug (IND) clinical trial approvals from the National Medical Products Administration for the treatment of adult relapsed or refractory acute lymphoblastic leukemia, relapsed or refractory aggressive B-cell non-Hodgkin lymphoma, and pediatric and adolescent relapsed or refractory B-cell acute lymphoblastic leukemia. Additionally, it received FDA IND approval in March this year for the treatment of adult r/r B-ALL.

CAR-T products shift from the drug mechanism mainly based on "killing". By utilizing the patient's own immune cells, which are cultured, expanded, or activated in vitro and then infused back into the patient’s body, they stimulate or enhance the immune function of the body to eliminate abnormal cells such as tumor cells, pathogens, or virus-infected cells.

With the launch of Naciorlen Injection, the currently approved in ChinaThe number of CAR-T products has reached four.In June 2021 and September 2021, the CAR-T product Axicabtagene Ciloleucel Injection from Fosun Kite, a joint venture of Fosun Pharma, and the CAR-T product Relmacabtagene Autoleucel Injection from JW Therapeutics were successively launched in China. Both are indicated for lymphoma.In July 2023, the CAR-T product Inebilizumab Injection, co-developed and commercialized by Innovent Biologics and Juventas, was approved for marketing in China, for the treatment of relapsed or refractory conditions.Multiple Myeloma (Adult patients with R/R MM who have progressed after at least 3 prior lines of therapy (including at least one proteasome inhibitor and one immunomodulatory agent).

Previously approved CAR-T products in China

Source: PharmaCloud China Drug Approval

FRUZAQLA (Fruquintinib) is a selective oral inhibitor of VEGFR-1, -2, and -3. VEGFR inhibitors play a crucial role in inhibiting tumor angiogenesis. FRUZAQLA is designed to have higher kinase selectivity, aiming to reduce off-target kinase activity, thereby enabling higher drug exposure, sustained target coverage, and greater flexibility when potentially used as part of combination therapy. To date, FRUZAQLA has demonstrated a manageable safety profile, and studies on its use in combination with other anti-cancer therapies are ongoing.

In 2007, fruquintinib was first synthesized as a small molecule structure in a laboratory located in Zhangjiang, Pudong, Shanghai, and was approved for marketing in China in 2018. Today, it has finally achieved a successful launch in the United States! The drug was included in the National Medical Insurance Catalog in January 2020, and its market currently covers 328 cities across China, reaching over 3,000 cancer hospitals. According to the PharmaCloud National Hospital Sales Data, as of the first half of 2023, the cumulative sales of this drug in hospitals exceeded 1 billion RMB. Reports indicate that fruquintinib holds a 47% market share among third-line colorectal cancer patients, benefiting more than 80,000 colorectal cancer patients.

Screenshot source:Pharmcube China Hospital Sales Database

The approval of FRUZAQLA was based on data from two large Phase III clinical trials, including: the international multicenter clinical trial FRESCO-2 study, whose data has also been published in The Lancet; and the FRESCO study conducted in China, whose data has also been published in JAMA. These studies explored FRUZAQLA in combination with best supportive care versus placebo in combination with best supportive care for the treatment of previously treated patients with metastatic colorectal cancer. Both the FRESCO and FRESCO-2 studies met their primary and key secondary endpoints, demonstrating consistent benefits among a total of 734 patients treated with FRUZAQLA. The safety profiles of each study were also consistent.

Data from the FRESCO and FRESCO-2 studies also supported the submission of the marketing authorization application for fruquintinib to the European Medicines Agency ("EMA"), which was confirmed and accepted in June 2023. Additionally, an application was submitted to the Pharmaceuticals and Medical Devices Agency ("PMDA") in Japan in September 2023. We look forward to the early approval of fruquintinib in Europe and Japan.

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